Generic ‘skinny’ labelling under threat in the US

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On 2 October 2021, GlaxoSmithKlein (GSK) was finally successful in challenging generics manufacturer Teva Pharmaceuticals (Teva) over its ‘skinny’ labelling of their beta blocker carvedilol, a generic version of Coreg.

Label prescription drugs

In the US, skinny labelling was introduced to help generics manufacturers avoid patent walls, or ‘thickets’, set up by originator manufacturers. In essence, a patent wall can be created every time a drug is approved for a new indication (such as a new disease) or a new use (such as in paediatric patients). This can add another 20 years to a patent lifetime and block generics market entry. However, as approved by US congress, skinny labelling allows generics manufacturers to market a product following approval for the unpatented uses of the drug only. This enables the generics company to avoid waiting until existing patents expire and negates the need for them to attempt to invalidate patents in court.

Until now this has been a success. However, Teva has lost the battle against GSK over the skinny labeling of Coreg, used to treat patients with congestive heart failure (CHF) and other cardiovascular disorders. Teva has been requested to pay over US$20 million in damages due to patent infringement.

In 2007, Teva launched their generic version of Coreg with a skinny label that included two indications but did not include the treatment for CHF indication as this was still under patent. The CHF indication was later reissued for GSK and in 2011, the US Food and Drug Administration requested that Teva amend its label to include the patented CHF indication. Now, despite GSK initially losing the case in 2019, the US Federal Circuit has found Teva liable for inducing others, mainly physicians, to commit patent infringement by prescribing the generic form of the drug for indications not on its label (between 2008 and 2011).

It is thought that this case will have immediate ill effects for patients taking generic versions of carvedilol who may now have to switch to the more expensive brand-name version. It also has the potential to threaten other skinny labelled products on the market, and those that may seek approval in the future.

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